Trans Women: Special Considerations for the Milli Vaginal Dilator

Key Takeaways 

• Milli is an FDA-cleared medical device with a specific labeled indication for use. It has not been designed or studied for post-vaginoplasty dilation or related uses.
• Using Milli for post-vaginoplasty dilation, vaginal stenosis from radiation or surgery, or vaginal hypoplasia maintenance is considered off-label use.
• Post-vaginoplasty dilation protocols typically require daily prolonged dilation at forces that may exceed Milli’s device specifications, which can lead to device breakage and potential injury.
• If you require dilation for any of these purposes, please work with your healthcare provider to identify an appropriate dilator and protocol for your specific situation.
• Materna Medical is committed to providing accurate, safe information for all individuals — regardless of whether Milli is the right tool for their situation.

What Milli Is Cleared For

The Milli vaginal dilator is an FDA-cleared medical device intended for controlled dilation of the vagina. When a medical device is FDA-cleared, it is granted a specific labeled indication for use. Milli’s labeled indication covers three uses:

• For an examination (by your doctor)
• In preparation for a surgical procedure that requires vaginal penetration
• To help relieve the symptoms of vaginismus (a condition that involves tightening of the vaginal muscles) and related painful sex

For full details on Milli’s risks, contraindications, warnings, and precautions, please visit the Milli safety information page.

What Milli Is Not Cleared For

Milli has not been designed or studied for safety and effectiveness when used for the following purposes:

• Dilation of the neovagina after gender-affirming surgery — vaginoplasty (male-to-female, MTF)*
• Maintaining patency after vaginoplasty for vaginal hypoplasia (e.g., Mayer-Rokitansky-Küster-Hauser syndrome)
• Treatment of vaginal stenosis due to scarring from pelvic surgery or radiation

If you require vaginal dilation for any of the above uses, this is not included in the Milli vaginal dilator labeling. This is considered an “off-label” use.

* Previously known as gender-reassignment surgery (GRS), sex-reassignment surgery (SRS), or gender-confirmation surgery (GCS).

Why Post-Vaginoplasty Dilation Requires a Different Approach

In the circumstances listed above, patients are asked to adhere to specific aftercare post-operative protocols requiring strict, daily prolonged dilation to achieve the desired outcomes (Callens et al., 2014; Massie et al., 2018). These purposes may require different tools and protocols due to the forces necessary for daily prolonged dilation. 

The daily vaginal dilation protocols and necessary forces may exceed the Milli device design specifications (Massie et al., 2018). This can lead to breakage of the device and potential injury to the vaginal tissue. 

If you require a vaginal dilator for daily prolonged dilation, please collaborate with your healthcare provider to explore alternative vaginal dilator options and suitable treatment plans tailored to your situation. 

Our Commitment to All Patients

At Materna Medical, we firmly believe that all individuals — Milli user or not — need access to accurate and safe medical information. We appreciate the emphasis on seeking alternative vaginal dilator options and appropriate protocols from healthcare providers for these situations. We always prioritize patient safety and following guidance from healthcare professionals.

Please consult your healthcare professional to ensure the best approach for your needs and desired outcomes.

“At Materna Medical, we firmly believe that all individuals — Milli user or not — need access to accurate and safe medical information. Patient safety and following guidance from healthcare professionals always comes first.”

FAQs

Can trans women use Milli after vaginoplasty?
Milli is not cleared for post-vaginoplasty dilation and has not been studied or designed for this use. Post-vaginoplasty dilation typically requires daily, prolonged sessions at forces that may exceed Milli’s device specifications, which could lead to device breakage and potential tissue injury. If you require dilation following vaginoplasty, please speak with your surgical team or healthcare provider about the appropriate device and protocol for your situation.

What does “off-label use” mean?
Off-label use means using an FDA-cleared or FDA-approved medical device or medication for a purpose not included in its cleared labeling. The FDA does not prohibit off-label use, but it does mean the device has not been specifically studied or cleared for that purpose. For uses outside Milli’s labeled indication, working with a healthcare provider to identify an appropriate tool is strongly recommended.

What is Milli’s FDA-cleared indication?
Milli is FDA-cleared for three uses: controlled vaginal dilation for an examination by a doctor; in preparation for a surgical procedure requiring vaginal penetration; and to help relieve the symptoms of vaginismus and related painful sex. Any use outside these three indications is considered off-label.

Why can’t Milli be used for post-vaginoplasty dilation?
Post-vaginoplasty aftercare protocols typically require strict, daily prolonged dilation to maintain the neovaginal canal. The forces required for these protocols may exceed Milli’s design specifications. Using a device beyond its specifications risks breakage and potential injury to delicate tissue. This is why a device specifically suited to post-surgical dilation protocols, selected in collaboration with your surgical or medical team, is the appropriate choice.

Where can I find more information about Milli’s safety and contraindications?
Full information about Milli’s risks, contraindications, warnings, and precautions is available on the Milli safety information page. The Instructions for Use also provides complete guidance on indicated uses, precautions, and care instructions.

Sources 

• Callens, N., De Cuypere, G., De Sutter, P., et al. (2014). An update on surgical and non-surgical treatments for vaginal hypoplasia. Human Reproduction Update, 20(5), 775–801. https://doi.org/10.1093/humupd/dmu024 

• Massie, J. P., Morrison, S. D., Van Maasdam, J., & Satterwhite, T. (2018). Predictors of patient satisfaction and postoperative complications in penile inversion vaginoplasty. Plastic and Reconstructive Surgery, 141(6), 911e–921e. https://doi.org/10.1097/PRS.0000000000004427